BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1033758 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00438
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFO THAT THIS BSC SALES REP (SR) CALLED TECHNICAL SERVICES (TS) WHILE FOLLOWING UP WITH THIS PT IN THE EMERGENCY ROOM. THE SR STATED THE ELECTROGRAM REVEALED INTERMITTENT LOSS OF CAPTURE WITH SOME PSUEDO FUSION COMPLEXES, HOWEVER, BACK UP PACES WERE BEING PROVIDED WITH AUTOMATIC CAPTURE (AC) PROGRAMMED ON. THE PT IS SYMPTOMATIC, COMPLAINING OF CHEST PAIN FROM THE VENTRICULAR PACES. THE SR NOTED P-WAVES WERE PRESENT, ALTHOUGH THE SR HAD TROUBLE SEEING THEM. SENSING IN THE ATRIUM IS AT 3.5MV AND THE DEVICE IS SET AT 0.5MV. AS OF THIS DATE, ALL PRODUCTS REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R